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Terminated

Digital Diagnost VE

FDA Recall Z-0270-04 · Posted 2003-12-24

Recall StatusTerminated
Product CodeKPR
Date Initiated2003-11-20
Date Terminated2005-01-13
Product Quantity70 devices total

Reason for Recall

The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall.

Firm Action

The firm mailed a recall letter to affected customers on November 20, 2003 notifying them of the problem. The letter states upgrades will be completed by the end of April 2004.

Root Cause

Other

Distribution Pattern

The firm distributed to medical facilities nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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